Invivoscribe Announces Updated Reimbursement for the LeukoStrat CDx FLT3 Mutation Assay to Select Newly Diagnosed FLT3-ITD Positive AML Patients Eligible for VANFLYTA in Japan

SAN DIEGO,May 26,2023 -- Invivoscribe is pleased to announce that their LeukoStrat CDx FLT3 Mutation Assay®has received updated reimbursement by Japan's Ministry of Health,Labor and Welfare (MHLW) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo's VANFLYTA® (quizartinib). The assay is available worldwide,both as a kit for purchase and as a testing service.

In June 2019,the LeukoStrat CDx FLT3 Mutation Assay was approved in Japan as a companion diagnostic for relapsed or refractory FLT3-ITD positive AML. As of May 25,2023,health insurance will now also cover use of the test for the selection of newly diagnosed FLT3-ITD positive patients.

The expanded insurance reimbursement was based on a pivotal clinical bridging study,which demonstrated assay concordance and that efficacy was maintained when patients were selected with the LeukoStrat CDxFLT3Mutation Assay compared to patients selected by theFLT3-ITD Clinical Trial Assay (CTA) in the pivotal QuANTUM-First trial,which formed the basis for the approval of VANFLYTA in newly diagnosedFLT3-ITD positive AML patients in Japan.

Based on these results,health insurance coverage in Japan will be expanded to include use of the companion diagnostic assay for identification of patients that may be eligible to receive front line treatment with VANFLYTA.

"We are proud to be Daiichi Sankyo's companion diagnostic partner as they offer the first FLT3 inhibitor approved as a de novo treatment option for patients with FLT3-ITD positive AML in Japan," said Jeffrey Miller,CEO and CSO at Invivoscribe. "This milestone demonstrates the utility of using the LeukoStrat CDx FLT3 Mutation Assay in international clinical trials,as well as Invivoscribe's focus on providing standardized diagnostic tests to improve the lives of cancer patients."

AML is a blood cancer that affects the blood and bone marrow and is characterized by the rapid growth of abnormal white blood cells.1 AML has the lowest 5-year survival rate (31.7%) among people diagnosed with leukemia.2About 25% of AML patients have a FLT3-ITD mutation,which contributes to the growth and survival of cancer cells and is associated with a poor prognosis.3

About Invivoscribe

Invivoscribe is a global,vertically-integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics®. For nearly thirty years,Invivoscribe has improved the quality of healthcare worldwide by providing high quality standardized reagents,tests,bioinformatics tools,and services to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies,providing expertise in diagnostic development and regulatory submission through commercialization of companion diagnostics. For additional information,please visit www.invivoscribe.com or contact us at inquiry@invivoscribe.com.

1https://www.cancer.net/cancer-types/leukemia-acute-myeloid-aml/introduction

2https://seer.cancer.gov/statfacts/html/amyl.html

3 Daver N et al. Leukemia (2019) 33:299–312.

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